medwireNews: Monthly treatment with anifrolumab provides long-term benefits in patient-reported health status and quality of life measures for people with systemic lupus erythematosus (SLE) that extend 4 years, suggests the TULIP-LTE study.
TULIP-LTE was a 3-year extension of two 1-year phase 3 US trials in which anifrolumab, a human monoclonal antibody targeting the type I interferon receptor, showed clinical efficacy compared with placebo in patients who had moderate-to-severe SLE despite receiving standard therapy including glucocorticoids and immunosuppressants.
The mean age of the participants was 42.8 years, 92% were women, 68% were White, and over 80% were receiving glucocorticoids including prednisone. Scores on the patient-reported quality-of-life Short Form 36-version 2 (SF-36v2) questionnaire at baseline of the original trials were “below age-matched and gender-matched norms from the USA in all domains,” say researchers Catharina Lindholm (AstraZeneca, Gothenburg, Sweden) and colleagues in The Lancet Rheumatology.
A total of 369 patients who completed the original trials entered the double-blind 3-year extension and continued to receive the treatment they were initially assigned. In all, 257 were receiving intravenous anifrolumab 300 mg every 4 weeks and 112 were receiving placebo. Investigators were permitted to add or amend background therapy, such as glucocorticoids and immunosuppressants, according to their clinical judgment.
In the exploratory post-hoc analysis of the extension study, patient-reported outcomes improved from baseline in both treatment groups; however, “measures were numerically greater with anifrolumab at most study timepoints,” say Lindholm et al.
At week 208, the least squares mean reductions in Patient Global Assessment scores of disease activity (where higher scores indicate worse global health) were 16.9 points with anifrolumab versus 14.6 points with placebo, translating to a numerical 2.3-point greater reduction with anifrolumab.
Anifrolumab treatment also resulted in numerically greater improvements from baseline in SF-36v2 scores at week 208, with least squares mean differences in scores compared with placebo of 3.7 points and 5.9 points in the mental health and bodily pain domains, respectively.
Lindholm and team conclude that, “in addition to the known improvements in clinical outcomes, reduced glucocorticoid use, and a tolerable safety profile associated with anifrolumab therapy, we report evidence of the long-term impact of anifrolumab treatment on different patient-reported outcomes.” However, they note that their study excluded people with active, severe lupus nephritis or severe neuropsychiatric SLE, leading to under-representation of some SLE subpopulations.
The investigators point out that patient-reported outcomes are particularly relevant when monitoring chronic complex diseases such as SLE, as “both disease activity and treatment-associated effects can reduce health-related quality of life and health status.”
In a linked editorial, Tanja Stamm, from the Medical University of Vienna in Austria, and co-authors agree that patients’ self-reporting is “an essential component of health outcome measurements.”
They explain that measuring subjective symptoms such as pain, fatigue, and wellbeing using sensors and clinical data is limited, as these methods “typically quantify functioning and disease severity rather than information about the patient’s experience.”
With recent advances in digital data collection, such as apps and web-based portals, patients can easily report symptoms as they notice them, which can be collected between clinical visits and used in monitoring and to maintain communication between patients and healthcare personnel, they say.
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Lancet Rheumatol 2025; doi:10.1016/S2665-9913(25)00022-0
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